"The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these product"...
Dimethyl sulfoxide can initiate the liberation of histamine and there has been occasional hypersensitivity reaction with topical administration of dimethyl sulfoxide. This hypersensitivity has been reported in one patient receiving intravesical RIMSO-50® (dmso) solution. The physician should be cognizant of this possibility in prescribing RIMSO-50® (dmso) solution. If anaphylactoid symptoms develop, appropriate therapy should be instituted.
Changes in the refractive index and lens opacities have been seen in monkeys, dogs, and rabbits given high doses of dimethyl sulfoxide chronically. Since lens changes were noted in animals, full eye evaluations, including slit lamp examinations, are recommended prior to and periodically during treatment.
Some data indicate that dimethyl sulfoxide potentiates other concomitantly administered medications.
Pregnancy Category C. Dimethyl sulfoxide caused teratogenic responses in hamsters, rats and mice when administered interperitoneally at high doses (2.5 to 12 g/kg). Oral or topical doses of dimethyl sulfoxide did not cause problems of reproduction in rats, mice and hamsters. Topical doses (5 g/kg frst two days, then 2.5 g/kg last eight days) produced terata in rabbits, but in another study, topical doses of 1.1 g/kg days 3 through 16 of gestation failed to produce any abnormalities. There are no adequate and well controlled studies in pregnant women. Dimethyl sulfoxide should be used during pregnancy only if the potential beneft justifes the potential risk to the fetus.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dimethyl sulfoxide is administered to a nursing woman.
Safety and effectiveness in children have not been established.
Last reviewed on RxList: 4/9/2009
This monograph has been modified to include the generic and brand name in many instances.
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